InnoScot Health is partnering on the development of a new network that will support and enhance the understanding of digital health innovators as they look to navigate the complex regulatory environment with their new products

The proposed network – led by University of Glasgow’s Digital Health Validation Lab (DHVL) – is in its first phase and is currently aiming to identify and address areas which are considered particularly challenging within the digital health regulatory landscape before looking to progress to a second phase.

The dynamic and rapidly evolving nature of such technologies has given rise to specific regulatory complexities faced by innovators and companies when developing fresh products.

By enabling a network that develops regulatory science approaches spanning the entire product development cycle, DHVL will aim to help innovators deliver high-impact innovations that can be scaled up to benefit the UK and worldwide healthcare systems.

However, in order to determine the network’s priorities, innovators across industry, academia, and healthcare are first invited to undertake a new survey that will help to determine the network’s priorities, ensuring that it focuses on priority areas of need.

The survey will serve to build an understanding of the key regulatory needs of digital health innovators.

A key feature of the network will be DHVL’s ability to generate real world clinical evidence to support regulatory submissions. This requirement for the digital health market is rapidly expanding, and is critical in assuring the safety, effectiveness, and compliance of digital health technologies such as apps, medical devices, and software solutions.

The network is being developed alongside partners including Canon Medical Research Europe, CENSIS, Filament STAC - Smart Things Accelerator Centre, and NHS Greater Glasgow and Clyde.

This development work is funded by Innovate UK as part of its UK Regulatory Science and Innovation Networks programme – a key initiative for harnessing the power of regulatory science to generate evidence and intelligence which informs regulatory policy and practice.

Head of Regulatory Affairs, Elaine Gemmell said: “We are proud to be partnering with the Digital Health Validation Lab and other key partners within Scotland and throughout the UK to develop this network and support pioneers in digital health innovation with ambitions to accelerate their ideas into clinical settings.

“This collaborative network will help to lay the groundwork for providing the vital knowledge and advice they need to achieve key regulatory milestones, while helping to break down barriers.

“Ultimately, we expect the network to support DHVL's wider aim of accelerating the development, validation, and route to market of digital health technologies, and we would urge innovators in this area to complete the survey to ensure the network responds to the needs of the ecosystem.”